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Acute PainNCT05658367

Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy

A study testing Aromatherapy massage with sesame- lavender oil mixed, Aromatherapy massage with sesame oil and Massage with parraffin oil in people with Acute Pain and Anxiety, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an interventional type three-group randomized controlled non-drug clinical trial aimed at targeting the acute pain content and anxiety level of aromatherapy arm treatment with a sesame oil and sesame lavender oil mixture performed with Simple Mastectomy (BM) / Modified Radical Mastectomy (MRM). Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Acute Pain, Anxiety, Mastectomy
What is being tested?
Aromatherapy massage with sesame- lavender oil mixed, Aromatherapy massage with sesame oil and Massage with parraffin oil
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesTurkey (Türkiye)
Study dates
17 May 2022to 25 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years and over,
  • literate,
  • Agreeing to participate in the study,
  • Person, place, and time orientation,
  • Visual (except for those with better vision using a visual aid), auditory communication difficulties (except for those with better hearing ability using a hearing aid) that will prevent them from understanding the information given and expressing the pain situation correctly,
  • No speech impediment/communication problem,
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  • Simple mastectomy (BM) and modified radical mastectomy (MRM) were performed,
  • Not using any TAT method,
  • Able to use technology (smartphone, computer, etc.),
  • Individuals with technology devices (smartphone, tablet, computer, etc.)

Who cannot join

  • Not speaking Turkish and illiterate in Turkish,
  • Those who are allergic to the oils to be used in the massage during the application,
  • Involved in a different study conducted in the clinic,
  • Breast prosthesis placed during surgery,
  • Having physical and cognitive problems at a level that cannot apply massage,
  • Individuals diagnosed with mood disorders (using any medication for depression, panic attacks, dysthymia, or bipolar disorder)
Show all 11Show fewer
  • Transferred to the intensive care unit in the postoperative period,
  • Severe bleeding, hematoma, seroma, nerve injury, or lymphedema developing in the postoperative period,
  • Developing an allergy to the oils to be used in the massage during the application,
  • Those who want to leave work voluntarily,
  • Individuals who do not comply with the working process and conditions will be excluded from the study.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Sisli Etfal Training and Research Hospital

    Istanbul, Eyalet/Yerleşke

  • Sisli Etfal Training and Research Hospital

    Istanbul, 34396

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Massage Made With Aromatherapy Oil After Mastectomy on Acute Arm Pain and Anxiety: a Randomized Controlled Study

This study is an interventional type three-group randomized controlled non-drug clinical trial aimed at targeting the acute pain content and anxiety level of aromatherapy arm treatment with a sesame oil and sesame lavender oil mixture performed with Simple Mastectomy (BM) / Modified Radical Mastectomy (MRM). It constitutes a total of 66 patients with the power to represent the universe. However, considering the losses that may occur during the study process, it was decided that it would be appropriate to include 90 patients, 36% more than the sample. Individuals receiving arm massage with sesame oil (Group I), individuals performing arm massage with sesame-lavender oil mixture (Group II), and individuals performing arm massage with paraffin oil (Group III) constitute the research groups. After obtaining the informed written consent of the participants who agreed to participate in the study, the randomization list created from the computer-based random numbers table will be used with the block randomization method to assign an equal number of people to all three groups. In the preoperative period, patients will be given an allergic sensitivity (patch) test of the oils to be used in the study to Groups 1 and 2, massage training will be given to all groups with the show-and-have method in the pre-operative period, a massage application brochure and video will be given, and information will be given on how to fill out the follow-up forms. H1: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces the severity of acute arm pain compared to massage with paraffin oil.H2: After simple mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with paraffin oil.H3: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces anxiety levels compared to massage with paraffin oil.H4: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with paraffin oil.H5: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with sesame oil.H6: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with sesame oil.

Read the detailed description

Breast cancer ranks first among the most common cancers in women in Turkey, and one out of every four women diagnosed in 2014 was breast cancer (Turkish Ministry of Health Public Health Institution, Turkey Cancer Statistics, 2017). Breast cancer is considered both a local and systemic disease. In the planning of the treatment, the decision of surgery is made by considering the stage of cancer, and the most frequently applied intervention is mastectomy, which involves the partial or complete removal of the breast tissue (Turkish Ministry of Health, General Directorate of Health Services. Breast Cancer Prevention, Screening, Diagnosis, Treatment, and Follow-up Clinical Guide, 2020; Tola et al., 2021). It is stated that in patients who have undergone breast surgery, especially during axillary lymph node dissection, due to the possibility of intercostobrachial nerve injury, pain, numbness, and weakness may be felt in the chest wall, arm, and shoulder in the postoperative period, acute/chronic, neuropathic and phantom pain, lymphedema may develop (Ozmen, 2012; Nemli et al., 2017). Post-operative pain decreases in the first few days, but in some patients, the severity of pain does not decrease or even increase despite post-operative pain management (Mc Mahon et al., 2013). Anxiety experienced by patients in the preoperative period, including breast cancer patients, is an important factor in the level of pain intensity felt after surgery (Stamenkovic et al., 2018; Kulkarni et al., 2017). Effective anxiety and acute pain management are important in terms of shortening the recovery period of the individual, reducing the treatment costs, preventing the occurrence of chronic pain, and increasing the quality of life. For this reason, it is mentioned that non-pharmacological methods can be used in addition to pharmacological treatment to assist treatment (Chou et al., 2016; Small and Laycock, 2020; Reisli et al., 2021). Today, it is known that aromatherapy has an important place among complementary and holistic therapy methods (Zor et al., 2021). However, it is stated that the studies on aromatherapy massage are weak in terms of evidence and more studies should be done on this subject (Ayik and Ozden, 2018). It is stated that aromatherapy oils are applied by inhalation method alone rather than applied with massage, there are few studies on the effectiveness of massage with aromatic oils, therefore more studies on aromatherapy massage should be done in the treatment of pain, anxiety, and depression (Crosby, 2018; Raffi, 2020).

It is seen that studies conducted after breast surgery are mostly focused on the development of chronic pain rather than acute pain intensity after surgery (Kulkarni et al., 2017). In the literature, the effects of aromatherapy massage on anxiety and acute pain severity in patients who are planning for breast surgery are examined, foot reflexology or classical massage (Dion et al., 2015) according to the massage area preferred by the patient in the postoperative period, classical massage applied to the chest region in the preoperative period (Dion et al., 2015). Xiao et al., 2018) there is research on interventions.

No clinical study was found that evaluated the severity of acute pain and anxiety level in the arm after Simple Mastectomy (SM) / Modified Radical Mastectomy (MRM) surgery with sesame oil, sesame-lavender oil mixture, and aromatherapy massage applied in the postoperative period. Therefore, the result of this study is important because it forms the basis for a clinical study.

With the results to be obtained from the research; It is aimed at better understanding the effects of these herbal-based agents in aromatherapy treatment, contributing to nurses' non-pharmacological treatment interventions, and providing quality care in the management of anxiety and acute pain in patients, and thus to provide new information to evidence-based nursing practices.

Being tested
Aromatherapy massage with sesame- lavender oil mixed, Aromatherapy massage with sesame oil, Massage with parraffin oil
Medical subject headings
Acute Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aromatherapy massage with sesame- lavender oil mixedProcedure or surgery

    Also called Group 1

    After the surgery, 3 hours after the painkiller application, the patients will massage their arms with sesame- lavender oil mixed for 15 minutes with classical massage manipulations.

  • Aromatherapy massage with sesame oilProcedure or surgery

    Also called Group 2

    After the surgery, 3 hours after the painkiller application, the patients will massage their arms with sesame oil for 15 minutes with classical massage manipulations.

  • Massage with parraffin oilProcedure or surgery

    Also called Group 3 (Placebo- Control)

    After the surgery, 3 hours after the painkiller application, the patients will massage their arms with paraffin oil for 15 minutes with classical massage manipulations.

Study groups in NCT05658367
Study groupRoleWhat they receive
Group 1Active comparator- Group I: The group applied arm massage with sesame oil
Receives: Procedure: Aromatherapy massage with sesame oil
Group 2Experimental- Group II: The group applied arm massage with a mixture of sesame-lavender oil
Receives: Procedure: Aromatherapy massage with sesame- lavender oil mixed
Group 3Placebo comparator- Group III (Control): The group applied arm massage with paraffin oil
Receives: Procedure: Massage with parraffin oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in NUMERICAL PAIN SCALE (NUMERİCAL RATING SCALE- NRS)

    It is based on the expression of pain intensity in numbers. In numerical scales, 0 points define the absence of pain, while the value of the number increases as the severity of pain increases, and 10 points indicate unbearable pain

    Measured: In the postoperative period, the patient's pain is recorded at 08:00 and 08:30, 20:00 and 20:30 with analgesic application, and at 11:00, 11:15 and 23:00 and 23:15 with massage application.

  2. STATUS ANXIETY SCALE

    It is a 20-item scale used to measure the instantaneous anxiety level of individuals.

    Measured: Instant anxiety data of the patient are recorded in the postoperative period, at the 15th minute after the massage.

Secondary outcomes (5)
  1. VITAL FINDINGS REGISTRATION FORM

    It is the form that includes the patient's body temperature.

    Measured: In the postoperative period, the patient's body temperature is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

  2. ANALGESIC FOLLOW-UP FORM

    In this form, information about the name, type, number/dose, route of administration and frequency of analgesic administered in the postoperative period is included.

    Measured: Data are taken from the patient's file during the hospitalization for 2 days.

  3. VITAL FINDINGS REGISTRATION FORM

    It is the form that includes the patient's pulse.

    Measured: In the postoperative period, the patient's pulse is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

  4. VITAL FINDINGS REGISTRATION FORM

    It is the form that includes the patient's respiratory.

    Measured: In the postoperative period, the patient's respiratory is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

  5. VITAL FINDINGS REGISTRATION FORM

    It is the form that includes the patient's blood pressure.

    Measured: In the postoperative period, the patient's blood pressure is recorded 0 minutes before the analgesic, 30 minutes after the analgesic, 0 minutes before the massage and 15 minutes after the massage.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start17 May 2022
  3. Primary completion25 Mar 2023
  4. Study completion25 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
The research was carried out to determine the effect of aromatherapy arm massage with sesame oil, sesame-lavender oil mixture, and paraffin oil on acute pain severity and anxiety level in women who underwent Interventional Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM). The study design arm is three groups and a randomized controlled, double-blind, drug-free clinical trial.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658367
Sponsor's protocol ID
mataseven
Status last verified
Apr 2026
First submitted
2 Dec 2022
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aromatherapy massage with sesame- lavender oil mixed, Aromatherapy massage with sesame oil and Massage with parraffin oil in people with Acute Pain and Anxiety, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in NUMERICAL PAIN SCALE (NUMERİCAL RATING SCALE- NRS) (time frame: In the postoperative period, the patient's pain is recorded at 08:00 and 08:30, 20:00 and 20:30 with analgesic application, and at 11:00, 11:15 and 23:00 and 23:15 with massage application.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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